EUCTR2018-002635-23-DKActive, not recruitingPhase 1
Highdose steroids in High Pain Responders undergoing total knee-arthroplasty - A randomized doubleblindet controlled trial.
Anaesthesia Department, Hvidovre Hospital, Capital Region of Denmark.0 sites88 target enrollmentStarted: July 18, 2018Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 88
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Age between 40 and 90.
- •- Booked for unilateral knee-arthroplasty.
- •- Is able to take part in the investigation(selfreporting of pain and nausea/vomitting)
- •- Understands Danish or English, or has a translator available.
- •- Chronic opioid-user with >29 mg morfine/day or equivalent other opioids and/or Pain Catastrophizing Scale-score of >20.
- •- Signatured written consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
Exclusion Criteria
- •- Insulin-dependent diabetes melitus.
- •- Ongoing treatment with systemic glucocorticoids or immunesuppressing treatment(apart from inhaled glucocorticoids).
- •- Pregnancy/Breastfeeding
- •- Allergies for the investigational drug.
- •- A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.
Investigators
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